It is well understood that microbiological pathogens on the hands transferred to other body parts such as the mouth, nose and eyes are the primary cause of infectious disease in humans. The actual scope of the damage caused by infections resulting from hand-borne pathogens is generally less known. Fully eighty percent of all infections ranging from the usually benign cold and more debilitating flu to the truly horrific deadly Ebola, and everything in between, are transmitted by touch. The average American will contract two to four cold or flu infections in a typical year, experience four to six significant gastrointestinal disruptions during the same period. Colds alone account for an annual loss of 300 million person days of work and school annually; flus cost Americans $10 billion a year in lost wages and medical expenditures in addition to the 20,000 to 50,000 deaths each year from complications of influenza infections. Additionally, over and above the readily recognized cause and effect of the rapid onset of miseries characterized by the likes of a Norwalk virus attack, there is a growing body of evidence and in some cases solid proof that many major chronic diseases like gastric ulcers, stomach cancer, heart disease, cervical cancer, ALS (Lou Gehrig's disease), and Alzheimer's, most characterized by a much delayed onset, are infectious germ-based diseases that follow the same hand-based route into the body as the common cold rhinovirus. The scope of this generally unrecognized hidden plague associated with infectious diseases has been discussed for years within the medical community and more recently has found its way into the popular press, Atlantic Monthly, February 1999, (“A New Germ Theory”). It is sobering to realize the risk of a hand-borne infection is not just the occasional case of the sniffles but possibly the source of a life-long debilitating disease, a crippling condition leading to an early death, or most terrible, a tragic living death that strangles all hope and affection. For years the famed Mayo Clinic has used the following blunt slogan in an attempt to drive home a point about the need for effective hand hygiene to combat serious diseases: “The ten worst sources of contagion are our fingers.”
Each year more than 2 million hospital acquired (nosocomial) infections occur in the United States, costing some $4.5 billion in additional charges. The Centers for Disease Control estimates more than one-third of healthcare associated infections can be prevented through better infection control programs of which hand cleaning is the centerpiece for reducing the spread of infection. Hospitals are only one of many organizations burdened with hand-borne disease costs. A recent school study found that classrooms that made hand sanitizing fluid dispensers simply available for use showed a 20% reduction in student absenteeism due to illness as well as a 10% decrease in teacher absenteeism. Several recent articles provide an understanding of the current level of technology available for hand sanitation and further describe the significant limiting problems the present art faces.
In March 2001 an American Journal of Nursing article (“Impact Rate of Compliance with Hand Antisepsis . . . ”) stated that 80,000 hospital deaths occur each year as a result of nosocomial infections contracted during their stays. Further, that “it's common knowledge that the hands of heath care workers can carry disease-causing organisms from one patient to another and that hand antisepsis before and after each patent contact is crucial to the prevention and control of nosocomial infection.” The reasons most often cited by hospital staff for failing to clean their hands adequately are inconvenience and no time. Given the hectic and demanding nature of their workload these are not excuses but simply statements of reality. That convenience and time are critical factors in maintaining hand sanitation is underscored by the finding in this study that placing hand sanitizing fluid dispensers “in the hallways outside patient rooms were nearly 30 times more likely to be used than dispensers mounted anywhere inside the rooms.” Yet the most disturbing finding of this study was that full compliance with hand antisepsis guidelines was an unrealistic goal. That while hand sanitizing fluids took less time than washing and the placement of numerous dispensers bottles made matters somewhat more convenient, even with the heightened attention impact of the study itself (the Hawthorne effect), compliance did not achieve more than 60% at any time during the study. And it is well understood that over time, after the study is done and gone, a drift back to much lower compliance rates is inevitable; the dispenser bottle becomes just one more thing in the room, like soap at the sink, rarely used and only when time and convenience allowed.
In March 2002 an article in Infection Control and Hospital Epidemiology (“Promotion of Hand Hygiene: Magic, Hype, or Scientific Challenge?”) restates the conditions for promoting adequate hand hygiene. “Among enabling factors, engineering control must be considered for the successful promotion of hand hygiene. In particular, it involves making hand hygiene easy, convenient, and possible in a timely fashion.” Another observation made is that the higher rates of compliance seen in studies can only be sustained when some form of cost-effective, non-intrusive monitoring is invented. “My personal opinion is that obtaining a sustained and never-ending Hawthorne effect associated with improved compliance with hand hygiene and decreased infection and cross-transmission rates should be the dream of every hospital epidemiologist. Let's find a cost-effective way to induce it.” This need remains yet unfilled in the marketplace and published art.
In July 2000 another article in Infection Control and Hospital Epidemiology (“Using Alcohol for Hand Antisepsis—Dispelling Old Myths”) the qualities and values of alcohol-based hand antiseptics are described. The author points out the cost benefits of hand sanitizing fluids in hospitals. “ . . . administrators should consider that modest increase in acquisition costs for alcohol-based hand hygiene products are tiny in comparison to excess hospital costs associated with nosocomial infections. If increased use of an alcohol gel or rinse reduces the number of serious nosocomial infections by a few a year, the cost savings from prevented infections should more than offset incremental costs of using alcohol-based preparations.” These offset costs are those the hospital would charge as operational costs. Not considered are the much more substantial costs of the damage awards issuing from pain and suffering lawsuits won by patient and their attorneys for the hospital's failure to follow best practice protocols.
In March 2001 an article in Emerging Infectious Diseases (“Antiseptic Technology: Access, Affordability, and Acceptance”) further reinforces the findings that time and convenience are critical compliance factors. Detailed costs of implementing a hand hygiene program are also provided.
A final article in the October 2000 issue of Family Medicine (“Alcohol-free Instant Hand Sanitizer Reduces Elementary School Illness Absenteeism”) reports a remarkable reduction in absenteeism when hand sanitizers were introduced in public school classrooms. Results showed students using hand sanitizing fluids “were found to have 41.9% fewer illness-related absence days, representing a 28.9% and a 49.7% drop in gastrointestinal- and respiratory-related illness, respectively. . . . Conclusion: Daily use of the instant hand sanitizer was associated with significantly lower rates of illness-related absenteeism.” In this study the close monitoring and continual instruction of the test group by teachers largely abrogated the issues of time and convenience. Nevertheless, it clearly indicates the significant impact consistent and rigorous hand sanitation can have in schools and the implications for parallel benefits at all levels of society are obvious. As the reports point out in describing the interlinking cost of disease “Even if one doesn't have school-age children, it is necessary to understand the importance and benefits of good hand hygiene, not only in clinical practice but also in the greater community. Vital tax dollars will be saved on expenses for remedial student services and employee work time by this simple and effective way to decrease illness-related absenteeism.”
That improved hand hygiene can be achieved by using various hand sanitizing fluids is beyond question, the problems preventing this known technique for achieving a high degree of use (compliance) are equally understood as being time required and convenience use. These same twin factors are true in the vastly greater pool of the general population, with the addition of a third very important factor—easy availability to achieve timely use, in a word, timeliness. In hospitals and schools availability is defined in terms of convenience and it has been repeatedly shown the placement of bottle dispensers in rooms, particularly by a door, leads to statistically significantly improvements in hand hygiene and related disease. It has also been shown that recidivism is immediate when compliance monitoring stops. For the general population an approach emphasizing wide distribution, ready access, convenient use, inconspicuous, omnipresence, and timely applications are key factors. The state of the art as defined by the marketplace and patent literature does not provide either methods or devices that adequately respond to these requirements. Dispensers hung on walls or set on counters have proven only marginally effective in even the controlled environments of hospitals and schools; in public their effectiveness rating falls to near zero. The answer lies in development of an inexpensive, disposable, multi-dose, small, convenient, self-sealing, ubiquitous, inconspicuous, and pocket carried packet dispenser of hand sanitizing fluid that can be accessed in a timely manner and reused several times during the course of a day's normal activities. Successful methods promoting the wide distribution of such packets would contribute to eventual habitual use.
There are only two types of pocket carried hand sanitizing fluid dispensers known to be currently offered in the marketplace. The first type is represented by a small bottle containing a 62% ethyl alcohol antimicrobial agent manufactured by Gojo Industries (http://66.181.86.144/cgi-bin/gojo/). It is a 15-milliliter translucent thermoformed bottle of hand sanitizing fluid with a snap cap closure with overall dimensions of 5×2.5×1.5 centimeters and some 18 cubic centimeters in volume. Dispersement is accomplished by popping open the snap lid, squeezing or shaking out several drops into an open hand, recapping the bottle, and returning it to a pocket. This dispenser has been in the marketplace since at least 1997. A second dispenser type that irregularly appears in the marketplace is a single-use metal foil packet containing 1.5-millilters of 60% ethyl alcohol with various herbal extracts and sometimes various emollients. Lafayette Promotional (http://216.223.163.4/products/hand_gel_packets.htm) is one of several distributors of this packet form. The foil packet typically measures 5×7.5×0.3 centimeters with a volume of about 2 cubic centimeters. Dispensing is accomplished by tearing the foil at a corner edge, pouring or squeezing out the fluid, and discarding the empty foil package. Both types of products appears to have achieved a degree of success in the marketplace as evidenced by their continued presence on the web, of the two the bottle is overwhelming more commonly found. There are literally dozens of other suppliers offering the same types of dispensers.
Why these two packaging styles have not met with more success in a potentially huge market has likely more to do with fashion, habit and convenient access than a failure of the public to appreciate the health threat poised by hand-borne pathogens. Many people understand and appreciate the need for clean hands but just fall far short in practice. It has proven so inconvenient to perform the frequent and necessarily timely hand rubbings that provide an effective level of protection that the habit has simply never become established in any significant population group. In the case of the bottle its size, particularly its thickness, creates such a noticeable bulge in a shirt or pants pocket that it makes a negative fashion statement only equaled by pocket protectors in high school; further, the highly visible process involved in handling the bottle during the act of dispensing definitely conveys an unfortunate phobic impression about the user. Despite the efforts of hundreds of school boards across the nation not even elementary kids could be persuaded to carry and regularly use these small bottles; it just isn't fashionable and certainly less than cool. In the case of the single-use foil packet the need to carry several, typically four to seven a day, plus the need to discard an empty packet each time, severely works against public acceptance. Further, the need for the antimicrobial material to be necessarily runny in order to be easily extracted from the opaque foil packet leads to loss of the material from the hand through accidental runoff, and increasing the viscosity leads to significant difficulty in emptying the foil packet in a expedient manner without an unfortunate degree of very unwelcome messiness. These and other shortcomings have left the only two known types of carried hand sanitizing fluid dispenser products with a somewhat limited public appeal. Based on an extensive review of commercial literature no other packaging techniques are known to be in the marketplace today nor could there be found any suggestion of a more effective alternative solution to the small bottle or the single-use foil packet approaches. There is a distinct and unmet need for a middle product, a hand sanitizing fluid dispenser that functionally fits between these current marketplace offerings. A product adequate for a full day's needs of four to seven rubbings, that is without bulk, operates in a self-sealing manner, can be accessed easily, permits discrete usage, and is sufficiently affordable to be omnipresent and disposable.
Other prior art as described in the patent literature offers few relevant disclosures and what could be found is discussed as follows. The pertinent patent art can be divided into four subject areas: Packets with Rupturable Barriers (6), Single-Use Packets (2), Tortuous Path Seals (4), and various Sealing Valves (6). There have been numerous prior art devices for dispensing liquids, but out of the entire prior art only one (Kocker U.S. Pat. No. 6,228,375) deals specifically with a disposable hand sanitizing fluid dispensing packet and an associated hand hygiene method based on the single-use packet. Kocker disclosed a packet that will be more fully described below in Single-Use Packets category. The other cited patents herein deal almost exclusively with techniques for opening, dispersing and sealing various packet configurations. As portions of the present invention use in unique configurations many of these features, in addition to a newly discovered deforming self-sealing choke valve and other original features, it is useful to review the prior art so novel differentiation and inventive fashions can be clearly delineated.
In the first group (Packets with Rupturable Barriers) there are six patents that are relevant in some fashion.    Miller U.S. Pat. No. 3,913,789 disclosed a fluid containing packet with a weakly sealed and thus breakable area in the peripheral seal which forms an opening when pressure is applied via a flexible wall to the contained fluid.    Strenger U.S. Pat. No. 4,759,472 disclosed a rupturable seal that when burst by fluid pressure flowed into a diverter area to meter out a controlled flow.    Farmer U.S. Pat. No. 4,872,556 disclosed a single portion packet with two seams that peel apart under pressure forming a discharge opening.    Lane U.S. Pat. No. 4,890,744 disclosed a single-use with one or more pressure rupturable frangible seals and controlled dispersing chamber.    Farmer U.S. Pat. No. 5,131,760 disclosed a single-use dual chamber dispenser with rupturable membranes to control the discharge of the fluid.    May U.S. Pat. No. 6,379,069 disclosed a tube dispenser with a rupturable dividing membrane with weakening folds and creases.
The present invention does not employ any rupturable membrane seals nor do any of the above disclose or suggest their usage in a hand sanitizing method. Two patents in the Single-Use group are as follows:    Kocher U.S. Pat. No. 6,228,375 disclosed a single-use, single chamber disposable packet containing a hand sanitizing fluid that is either dispersed as a spray when a seal bursts under pressure or a tear is made in the packet. A method using single-use packets for hand sanitation is claimed.    Sokolsky U.S. Pat. No. 6,360,916 disclosed a single-serving condiment pouch employing a trapezoidal shaped configuration and opening to dispense a flat ribbon of food condiment.
Neither of the two single-use packets disclose or suggest the multidose, seal-sealing valve packets, or methods using same of the present invention. Four patents in the Tortuous Path Seal group are as follows:    Kaplan U.S. Pat. No. 2,707,581 disclosed a flexible dispensing container with a tortuous passage serving as a spring check valve which allows fluid to flow when placed under pressure.    Jamison U.S. Pat. No. 4,491,245 discloses a flow channel with a serpentine configuration and a spout tear for dispersement.    Billman U.S. Pat. No. 5,018,646 disclosed a serpentine discharge configuration protected from being deformed by wall indentations of the container.    Zakensberg U.S. Pat. No. 5,839,609 disclosed a tortuous path valve of thermoformed ridges and recesses to form a positive seal for the pack.
None of the four Tortuous Path group disclosed or suggested a deforming self-sealing valve/choke of the present invention nor do they disclose or suggest any hand sanitizing method. The final group, Sealing Valves, with six patents are as follows:    Volckening U.S. Pat. No. 3,184,121 disclosed a flexible package with a discharge outlet passage of resilient material capable of self-closing following a pressure induced passage of fluid.    Brown U.S. Pat. No. 3,278,085 disclosed a liquid squeeze tube with a fold over flap seal for containing the remaining fluid following a use.    Hellstrom U.S. Pat. No. 3,635,376 disclosed a package container with a snap open/close valve of tensed flexible sheets to control flow.    Haggar U.S. Pat. No. 4,328,912 disclosed a dispensing package using a convex/concave pop valve to control a flow channel and thus regulate multiple doses.    Chan U.S. Pat. No. 5,529,224 disclosed a self-closing liquid dispensing package with a self-sealing flat channel valve that relies on pre-tensed resilience to resealing following pressure induced dispersement from a thermoformed reservoir.    Farmer U.S. Pat. No. 6,244,468 disclosed use of a spaced pair of pre-tensed transverse creasing folds as a self-sealing valve for dispersing liquid soaps by a stripping action.
None of the six Sealing Valves disclosed or suggested a deforming self-sealing choke valve of the present invention nor do they indicate any use in a hand sanitizing method. No prior art in either the literature or patents could be found which addressed the use of lottery or gaming promotion techniques associated with hand sanitizing fluid dispensers and packaging thereof.
The above discussed current practices and known forms of dispensers together with various packaging types, all were found deficient in several respects. Significantly, none of the above references taken in part or as a whole presents a convenient, timely, and effective way of facilitating the use of hand sanitizing fluids achievable by means of a small, flat, clear, disposable, twin chambered, multi-dose, self-sealing, polymer, pocket carried packet. None overcome the recognized problems of timeliness, convenience, and accessibility provided by the advancement to the art the present invention contributes.